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Study aim
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Determining and comparing the effectiveness of intratympanic corticosteroids in comparison with standard treatment on patients' hearing status
- Determining and comparing the effectiveness of intratympanic corticosteroids in comparison with standard treatment on the tympanogram status of patients
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 72 patients. The order of referral was used for randomization.
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Settings and conduct
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The study is conducted in Taleghani Hospital, Tehran, in the Otolaryngology Clinic
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Participants/Inclusion and exclusion criteria
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In this study, all adult patients over 12 years of age with unilateral or bilateral serous otitis who referred to Taleghani Hospital from 1402 to 1403 will be examined. In this study, adult patients with serous otitis, who have a gap of 10-30 dB in the PTA test and have a type B tympanometry, and after one month from the onset of the disease, there is still no change in PTA and tympanometry, are included in the study. Treatment is done after sinus endoscopy and sampling.
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Intervention groups
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For treatment, in the control group standard treatment (treatment with saline irrigation 4 times a day and inhaled fluticasone nasal spray 125 micrograms/dose in the form of bilateral puffs every 12 hours and follow-up) and in the study group, in addition to receiving standard treatment similar to the injection control group Cortone (methylprednisolone 50 mg) is injected intratympanically under local anesthesia with lidocaine mesh for patients, and then follow-up is done with PTA test and tympanometry every month for up to three months. And finally, the results are compared with the group that only received the standard treatment
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Main outcome variables
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More complete treatment for serous otitis and prevention of the need for surgery